Or. Admin. Code § 333-116-0687

Current through Register Vol. 64, No. 1, January 1, 2025

Section 333-116-0687 - Training for Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Greater than 1.22 Gigabecquerels (33 millicuries)

Except as provided in OAR 333-116-0740, the licensee must require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all of the requirements in subsection (3)(a) and (3)(b) of this rule and whose certification has been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State. The names of board certifications that have been recognized by the U.S. Nuclear Regulatory Commission or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web page; or

(2) Is an authorized user under OAR 333-116-0680 for uses listed in OAR 333-116-0680(2)(b)(F)(ii), or equivalent NRC or Agreement State requirements; or

(3) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive.

(a) The training must include:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(b) Has work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0680, 333-116-0687, 333-116-0740, or equivalent NRC or Agreement State requirements. A supervising authorized user, who meets the requirements in OAR 333-116-0680(2), must have experience in administering dosages as specified in OAR 333-116-0680(2)(b)(F)(ii). The work experience must involve:

(A) Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;

(C) Calculating, measuring and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and

(c) Has obtained written attestation that the individual has satisfactorily completed the requirements in subsections (3)(a) and (3)(b) of this rule, and is able to independently fulfill the radiation duties as an authorized user for the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical use authorized by OAR 333-116-0360 The written attestation must be obtained from either:

(A) A preceptor authorized user who meet the requirements in OAR 333-116-0680, 333-116-0687, 333-116-0740, or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, and has experience in administering dosages as specified in OAR 333-116-0680(2)(b)(F)(ii); or

(B) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in OAR 333-116-0680, 333-116-0687, 333-116-0740 or equivalent U.S. Nuclear Regulatory Commission or Agreement State requirements, has experience in administering dosages as specified in OAR 333-116-0680(2)(b)(F)(ii), and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subsections (3)(a) and (3)(b) of this rule.

Or. Admin. Code § 333-116-0687

PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14; PH 24-2014, f. & cert. ef. 8-15-14; PH 68-2018, minor correction filed 02/01/2018, effective 2/1/2018; PH 81-2021, amend filed 11/19/2021, effective 11/23/2021; PH 173-2022, minor correction filed 08/11/2022, effective 08/11/2022; PH 184-2022, minor correction filed 08/29/2022, effective 8/29/2022

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807